Drugs

Rep. Kim Reintroduces Drug Recall Authority Bill

U.S. Representative Andy Kim (D-NJ) has reintroduced his Protecting Americans from Unsafe Drugs Act which would provide FDA with mandatory recall authority for any and all faulty or unsafe prescription and over-the-counter drugs. Over the years, several bills have been introduced to give the agency this recall authority, but they never make it over the finish line. In a statement, Kim says his bill is in line with the FDA mandatory recall authority proposal included within the Biden Administration’s FY 2024 budget announced last month.

“Currently, FDA does not have mandatory recall authority even though they have had this long-standing authority for food products since 2011, and were just recently afforded this authority for cosmetic products in the 2023 omnibus bill,” Kim says. Because FDA does not have the express authority, its main recourse is asking drug manufacturers to conduct voluntary recalls, a “process that an unscrupulous manufacturer could refuse,” he says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome